VAX014 intravesicular / Vaxiion Therap - LARVOL DELTA

A Phase 1 Study of Intravesical VAX014 for Instillation in Subjects With Non-Muscle Invasive Bladder Cancer (clinicaltrials.gov) - P1 | N=6 | Completed | Sponsor: Vaxiion Therapeutics | Active, not recruiting ➔ Completed | Trial completion date: Dec 2022 ➔ Mar 2023 | Trial primary completion date: Dec 2022 ➔ Mar 2023

Trial completion • Trial completion date • Trial primary completion date • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor • Urothelial Cancer

VAX014 for instillation in subjects with nonmuscle-invasive bladder cancer. (ASCO-GU 2022) - "These clinical and preclinical data support the further development of VAX014 for the intravesical treatment of NMIBC and set a foundation for combination therapy with systemically administered immune checkpoint blockade in subjects with advanced disease."

Clinical • IO biomarker • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor • Urothelial Cancer

A Phase 1 Study of Intravesical VAX014 for Instillation in Subjects With Non-Muscle Invasive Bladder Cancer (clinicaltrials.gov) - P1 | N=6 | Active, not recruiting | Sponsor: Vaxiion Therapeutics | Recruiting ➔ Active, not recruiting | N=25 ➔ 6 | Trial completion date: Nov 2021 ➔ Dec 2022 | Trial primary completion date: Nov 2021 ➔ Dec 2022

Enrollment change • Enrollment closed • Trial completion date • Trial primary completion date • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor • Urothelial Cancer

Intravesical VAX014 Synergizes with PD-L1 Blockade to Enhance Local and Systemic Control of Bladder Cancer. (PubMed, Cancer Immunol Res) - "Finally, VAX014's target integrins α3β1 and α5β1 were overexpressed in tumor biopsies from advanced stage bladder cancer patients, as well as in both the MB49 and MBT-2 orthotopic mouse models of bladder cancer. These collective findings provide rationale for clinical investigation of VAX014 and systemic PD-1/PD-L1 blockade in advanced stage bladder cancer."

Journal • Bladder Cancer • Genito-urinary Cancer • Immune Modulation • Immunology • Inflammation • Oncology • Solid Tumor • Urothelial Cancer • CD4 • CD8 • IFNG

Vaxiion Therapeutics Announces Clearance of IND Application for the Intralesional Administration of VAX014 to Subjects with Treatment Refractory Solid Tumors (Businesswire) - "Vaxiion Therapeutics....announced the U.S. Food and Drug Administration has cleared the company’s Investigational New Drug application (IND) for VAX014 for investigational use in the intralesional treatment of solid tumors refractory to standard treatment options....Vaxiion will soon initiate a multi-center, open label Phase 1 dose escalation study to evaluate the safety, tolerability, and initial antitumor activity in both treated and untreated lesions following intralesional administration of VAX014."

IND • New P1 trial • Bladder Cancer • Genito-urinary Cancer • Oncology • Urothelial Cancer

A Phase 1 Study of Intravesical VAX014 for Instillation in Subjects With Non-Muscle Invasive Bladder Cancer (clinicaltrials.gov) - P1; N=25; Recruiting; Sponsor: Vaxiion Therapeutics; Trial completion date: Nov 2020 ➔ Nov 2021; Trial primary completion date: Nov 2020 ➔ Nov 2021

Clinical • Trial completion date • Trial primary completion date • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor • Urothelial Cancer